ClinicalTrials.gg
CompletedNCT07371169Updated Feb 23, 2026

Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance

An interventional study of Chromium picolinate and Placebo matching Chromium Picolinate in Insulin Resistance and Acanthosis Nigricans, sponsored by Uruk University. Completed at 1 site in Iraq. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Uruk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if chromium picolinate can reduce the severity of acanthosis nigricans and improve insulin resistance in adolescents with both conditions. It will also learn about the safety of chromium picolinate use in this age group. The main questions it aims to answer are:

  1. Does chromium picolinate reduce the severity of acanthosis nigricans as measured by the Burke quantitative scale for acanthosis nigricans severity in adolescents with insulin resistance?
  2. Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
  3. What medical problems do participants have when taking chromium picolinate? Researchers will compare chromium picolinate to placebo to see if chromium picolinate is effective in reducing acanthosis nigricans severity and improving insulin resistance.

Participants will:

  1. Take chromium picolinate or placebo daily for 24 weeks.
  2. Acquire baseline assessment and then visit the clinic at 8 weeks, 16 weeks, and 24 weeks for clinical evaluation, acanthosis nigricans severity assessment using the Burke quantitative scale for acanthosis nigricans severity, laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, and monitoring for any side effects or complications.
02

Conditions studied

  • Insulin Resistance
  • Acanthosis Nigricans

Browse trials for

Keywords

  • Chromium Picolinate
  • Insulin resistance
  • Acanthosis Nigricans
03

In context

Insulin Resistance

2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.

This study's enrollment of 90 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Uruk University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescent patients of both sexes, aged 12 to 18 years.
  • Clinically diagnosed with acanthosis nigricans.
  • Present Insulin resistance, defined as Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
  • Willing to participate in the study, with written provided by both the patient and guardian.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of type 1 or type 2 diabetes mellitus.
  • Known to chromium or any of the capsule .
  • Use of insulin-sensitizing medications (e.g., metformin, thiazolidinediones) within 3 months before screening.
  • Use of systemic or other medications known to affect glucose metabolism within 3 months before screening.
  • Significant renal disease (estimated \< 60 mL/min/1.73 m²) or liver disease ( or aspartate aminotransferase > 2.5 times the ).
  • Pregnancy or lactation.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Chromium Picolinate

    Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period.

    Drug: Chromium picolinate

  • Placebo comparator
    Placebo Control

    Participants in this arm (n=45) will recieve oral placebo capsules matching the shape size and color of Chromium Picolinate, once daily during the 24-weeks study period; they will act as the control group.

    Drug: Placebo matching Chromium Picolinate

Interventions

  • Chromium Picolinate Cap. 200mcg once daily for 24-weeks.

  • DrugPlacebo matching Chromium Picolinate

    An inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily.

06

What researchers measure

Primary outcomes

  1. Change in the clinical severity of Acanthosis Nigricans

    Acanthosis nigricans clinical severity will be measured using Burke's quantitative scale by a trained physician. This scale involves the summation of five parameters representing the severity of Acanthosis Nigricans, which are Neck severity (0-4), Neck texture (0-3), axilla severity (0-4), elbows (0 if Absent, 1 if present), knuckles (0 if Absent, 1 if present), and knees (0 if Absent, 1 if present). The minimum score of this scale is 0, and the maximum is 14. The primary outcome is the difference in acanthosis nigricans severity between the chromium picolinate group and the placebo control group.

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment

  2. Change in the severity of insulin resistance

    The severity of insulin resistance will be measured using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), this involves taking a fasting blood sample to measure plasma glucose and serum insulin and applying the formula (HOMA-IR = (Fasting insulin \[µIU/mL\] × Fasting glucose \[mg/dL\]) / 405). The primary outcome is the difference in insulin resistance severity based on HOMA-IR results between the chromium picolinate group and the placebo control group.

    Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks

07

Study locations

1 site
  • Baghdad Medical City / Children Welfare Teaching Hospital / Department of Endocrinology
    Baghdad, Baghdad Governorate 10045, Iraq
08

References and documents

Individual participant data

Plan to share: Yes — De-identified participant-level data, including acanthosis nigricans severity measurements, insulin resistance severity status, baseline demographics, and follow-up data relevant to primary outcomes.

Time frame: Upon publication of the trial result on open access repository.

Access criteria: Access will be open to researchers and the public via a free, open-access data repository, with a DOI provided in the publication. Data will be de-identified to protect participant privacy.

Data sharing details ↗ · www.zenodo.org

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Jan 2026, 12 months.

Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.

Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2026
First posted
Jan 27, 2026
StartActual
Jan 1, 2025
Primary completionActual
Jan 1, 2026
CompletionActual
Jan 1, 2026
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07371169
Lead sponsor
Uruk University
Responsible party
Ghasak kais Abdulhussain (Lecturer in department of Pharmacology (B.Sc , M.Sc, Ph.D) / College of Pharmacy, Uruk University) — Principal investigator
First posted
Jan 27, 2026
Start date
Jan 1, 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026
Last update
Feb 23, 2026

Study contacts

Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology)
principal investigator · Uruk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Picolinic acid

Start the discussion